Dental Direkt GmbH
DE-MF-000006592 · Germany · Spenge
Dental Direkt GmbH is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 28 |
|---|---|
| Class IIb | 24 |
Among these devices, 24 are declared implantable.
Devices declared under this manufacturer
- DD Prefab DFX 55 Set
- DD base P HI 98H20 dark pink
- DD base P HI 98H20 gingiva 3
- DD base P HI 98H25 dark pink
- DD base P HI 98H25 pink
- DD base P HI 98H25 sun
- DD base P HI 98H30 gingiva 4
- DD base P HI 98H30 pink
- DD cubeY® HL 98H20 0M2
- DD cubeY® HL 98H20 A2
- DD cubeY® HL 98H20 B1
- DD cubeY® HL 98H20 C1
Showing 12 of 52 declared devices.
Catalogue references include 96317, 96345, 96384, K50125, K50130, K50325.
European nomenclature codes declared: Q010699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Dental Direkt GmbH (DE) · FDA 3008347275 |
| Devices in EUDAMED | 52 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DENTAL DIREKT GMBH |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 4 |
| First licensed | 2010-12-08 |
Licence types: Device Family (3), System (2).
Licensed under: NACERA PEARL + SHELL (ZIRCONIUM OXIDE CERAMICS, DD BIO Z, DD BIO SPLINT FLEX, DD CONTRAST, DD MEDICAL POLYMERS (PMMA).
North American profile: Both markets. Dental Direkt GmbH is registered in both the United States and Canada.